Devices, systems and methods for medicament delivery

ABSTRACT

An apparatus includes a container defining an internal region configured to contain multiple medicament delivery devices, such as, for example, pen injectors, auto-injectors, inhalers or the like. The container includes an electronic circuit system configured to output a first electronic output associated with a first medicament delivery device contained within the internal region when the first medicament delivery device is removed from the internal region of the container. The electronic circuit system is further configured to output a second electronic output associated with a second medicament delivery device contained within the internal region when the second medicament delivery device is removed from the internal region of the container. The second electronic output is different than the first electronic output. At least one of the first electronic output or the second electronic output is associated with a use instruction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/621,236, entitled “Devices, Systems and Methods forMedicament Delivery,” filed Jan. 9, 2007 now U.S. Pat. No. 7,731,686,which is a continuation-in-part of U.S. patent application Ser. No.10/572,148, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Mar. 16, 2006, which is a national stage filing under35 U.S.C. §371 of International Patent Application No.PCT/US2006/003415, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Feb. 1, 2006 now U.S. Pat. No. 7,749,194, which claimspriority to U.S. Provisional Application Ser. No. 60/648,822, entitled“Devices, Systems and Methods for Medicament Delivery,” filed Feb. 1,2005 and U.S. Provisional Application Ser. No. 60/731,886, entitled“Auto-Injector with Feedback,” filed Oct. 31, 2005, each of which isincorporated herein by reference in its entirety. This applicationclaims priority to U.S. Provisional Application Ser. No. 60/787,046,entitled “Devices, Systems and Methods for Medicament Delivery,” filedMar. 29, 2006, which is incorporated herein by reference in itsentirety.

BACKGROUND

The invention relates generally to a medical device, and moreparticularly to a container for containing medicament delivery devices.

Exposure to certain substances, such as, for example, peanuts,shellfish, bee venom, certain drugs, toxins, and the like, can causeallergic reactions in some individuals. Such allergic reactions can, attimes, lead to anaphylactic shock, which can cause a sharp drop in bloodpressure, hives, and/or severe airway constriction. Accordingly,responding rapidly to mitigate the effects from such exposures canprevent injury and/or death. For example, in certain situations, aninjection of epinephrine (i.e., adrenaline) can provide substantialand/or complete relief from the allergic reaction. In other situations,for example, an injection of an antidote to a toxin can greatly reduceand/or eliminate the harm potentially caused by the exposure. Becauseemergency medical facilities may not be available when an individual issuffering from an allergic reaction, some individuals carry a medicamentdelivery device, such as, for example, an auto-injector, to rapidlyself-administer a medicament in response to an allergic reaction.

For a variety of reasons, however, some individuals who are susceptibleto allergic reactions may not carry such a medicament delivery device.For example, some individuals may not be aware of their susceptibilityto allergic reactions. Other individuals may be are aware of theirsusceptibility but may, at times, forget to carry a medicament deliverydevice and/or leave it in a location where it is impractical to use inan emergency. In some situations, the consequences of an individualleaving home without having a medicament delivery device can becompounded when, for example, the individual is going to an environmentthat poses a greater likelihood of exposure to the substances that cantrigger an allergic reaction. For example, an individual who is allergicto peanuts may be at a much greater risk when eating at a restaurantthan when eating at home.

Moreover, some known medicament delivery devices require several stepsto deliver the medicament into the patient. For example, to actuate someknown auto-injectors, the user must remove a protective cap, remove alocking device, place the auto-injector in a proper position against thebody and then press a button to actuate the auto-injector. Failure tocomplete these operations properly can result in an incomplete injectionand/or injection into an undesired location of the body. In certaininstances, for example, users who have become confused in the operationof some known auto-injectors have inadvertently injected the medicamentinto their thumb by improperly positioning the auto-injector.

The likelihood of improper use of known medicament delivery devices canbe compounded by the nature of the user and/or the circumstances underwhich such devices are used. For example, many users are not trainedmedical professionals and may have never been trained in the operationof such devices. Moreover, in certain situations, the user may not bethe patient, and may therefore have no experience with the medicamentdelivery device. Similarly, because some known medicament deliverydevices are configured to be used relatively infrequently in response toan allergic reaction or the like, even those users familiar with thedevice and/or who have been trained may not be well practiced atoperating the device. Finally, such devices are often used during anemergency situation, during which even experienced and/or trained usersmay be subject to confusion, panic and/or the physiological effects ofthe condition requiring treatment.

Some known medicament delivery devices include printed instructions toinform the user of the steps required to properly deliver themedicament. Such printed instructions, however, can be inadequate forthe class of users and/or the situations described above. Moreover,because some known medicament delivery devices, such as, for example,auto-injectors, pen injectors, inhalers or the like, can be compact,such printed instructions may be too small to read and comprehend duringan emergency situation.

Thus, a need exists for a container for medicament delivery devices thatcan be located in environments in which some individuals may have ahigher than normal risk of having an allergic reaction. Additionally,such containers should provide instructions for using the medicamentdelivery devices contained therein that can be easily understood by anuntrained user in any type of situation.

SUMMARY

Apparatuses for containing medicament delivery devices are describedherein. In one embodiment, an apparatus includes a container defining aninternal region configured to contain multiple medicament deliverydevices, such as, for example, pen injectors, auto-injectors, inhalersor the like. The container includes an electronic circuit systemconfigured to output a first electronic output associated with a firstmedicament delivery device contained within the internal region when thefirst medicament delivery device is removed from the internal region ofthe container. The electronic circuit system is further configured tooutput a second electronic output associated with a second medicamentdelivery device contained within the internal region when the secondmedicament delivery device is removed from the internal region of thecontainer. The second electronic output is different than the firstelectronic output. At least one of the first electronic output or thesecond electronic output is associated with a use instruction of thefirst medicament delivery device and/or the second medicament deliverydevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIGS. 4-6 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

FIG. 7 is a schematic illustration of a medical device according to anembodiment of the invention.

FIG. 8 is a perspective view of a medical device according to anembodiment of the invention in a first configuration.

FIG. 9 is a perspective view of the medical device shown in FIG. 8 in asecond configuration.

FIG. 10 is a perspective view of the medical device shown in FIG. 8 in athird configuration.

FIG. 11 is a schematic illustration of a portion of a medical deviceaccording to an embodiment of the invention.

FIGS. 12-14 are schematic illustrations of a medical device according toan embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a container defining aninternal region configured to contain multiple medicament deliverydevices, such as, for example, pen injectors, auto-injectors, inhalersor the like. The container includes an electronic circuit systemconfigured to output a first electronic output associated with a firstmedicament delivery device contained within the internal region when thefirst medicament delivery device is removed from the internal region ofthe container. The electronic circuit system is further configured tooutput a second electronic output associated with a second medicamentdelivery device contained within the internal region when the secondmedicament delivery device is removed from the internal region of thecontainer. The second electronic output is different than the firstelectronic output. At least one of the first electronic output or thesecond electronic output is associated with a use instruction of thefirst medicament delivery device and/or the second medicament deliverydevice.

In some embodiments, an apparatus includes a container defining aninternal region configured to contain multiple medicament deliverydevices. The container includes an electronic circuit system configuredto output a first electronic output associated with a first medicamentdelivery device contained within the internal region when the firstmedicament delivery device is removed from the internal region of thecontainer. The first medicament delivery device includes a labelconfigured to output a signal associated with at least one of a contentsof the first medicament delivery device, an expiration date of the firstmedicament delivery device, a dosage of the first medicament deliverydevice or a use instruction associated with the first medicamentdelivery device. In this manner, the first electronic output can beassociated with the signal received by the electronic circuit system.The electronic circuit system is further configured to output a secondelectronic output associated with a second medicament delivery devicecontained within the internal region when the second medicament deliverydevice is removed from the internal region of the container. The secondelectronic output is different than the first electronic output. Atleast one of the first electronic output or the second electronic outputis associated with a use instruction of the first medicament deliverydevice and/or the second medicament delivery device.

In some embodiments, a kit includes a medicament delivery device and acontainer. The container defines an internal region configured tocontain the medicament delivery device. The container includes a movableportion, an electronic circuit system, a first switch and a secondswitch. The movable portion has a first position, in which the movableportion covers the internal region of the container, and a secondposition, in which the internal region of the container is exposed to anarea outside the container. The first switch is configured to movebetween a first state and a second state when the movable portion movesbetween its first position and its second position. The first switch isoperatively coupled to the electronic circuit system such that theelectronic circuit system is configured to output a first electronicoutput when the first switch is moved from its first state to its secondstate. The first electronic output can be, for example, a visual output,an audible output or a haptic output. The second switch is configured tomove between a first state and a second state when the medicamentdelivery device is removed from the internal region of the container.The second switch is operatively coupled to the electronic circuitsystem such that the electronic circuit system is configured to output asecond electronic output when the second switch is moved from its firststate to its second state. The second electronic output, which includesan instruction for using the medicament delivery device, can be, forexample, a visual output (e.g. a video showing the proper use of themedicament delivery device), an audible output (e.g., a voice recordingproviding instructions for use) or a haptic output (e.g., a vibrationindicating the location of a particular item).

In some embodiments, an apparatus includes a container, a retainer andan electronic circuit system. The container defines an internal regionconfigured to contain at least a portion of a medicament deliverydevice, such as, for example a pen injector. The retainer is configuredto be movably coupled to the container and to retain the portion of themedicament delivery device within the internal region defined by thecontainer. The electronic circuit system is configured to output a firstelectronic output when the retainer is moved relative to the containerand a second electronic output when the medicament delivery device isremoved from the internal region. At least one of the first electronicoutput or the second electronic output is associated with an instructionfor using the medicament delivery device.

In some embodiments, an apparatus includes a container, a retainer, anelectronic circuit system and a label. The container defines an internalregion configured to contain at least a portion of a medicament deliverydevice, such as, for example a pen injector. The retainer is configuredto be movably coupled to the container and to retain the portion of themedicament delivery device within the internal region defined by thecontainer. The label is configured to be coupled to the medicamentdelivery device and contain information associated with the medicamentdelivery device in a machine-readable format. The electronic circuitsystem is configured to output a first electronic output when theretainer is moved relative to the container and a second electronicoutput when the medicament delivery device is removed from the internalregion. The electronic circuit system is further configured to receivethe information contained on the label include at least a portion of theinformation in the first electronic output and/or the second electronicoutput. At least one of the first electronic output or the secondelectronic output is associated with an instruction for using themedicament delivery device.

FIGS. 1-3 are schematic illustrations of a medical device 100 accordingto an embodiment of the invention in a first configuration, a secondconfiguration and a third configuration, respectively. The medicaldevice 100 includes a container 110 including an electronic circuitsystem 130 and defining an internal region 112. The internal region 112is configured to contain one or more medicament delivery devices.Disposed within the internal region 112 are at least a first medicamentdelivery device 150 and a second medicament delivery device 152. Thefirst medicament delivery device 150 and/or the second medicamentdelivery device 152 can be any suitable medicament delivery device, suchas, for example, an auto-injector, a pen injector, an inhaler or thelike.

As shown in FIG. 2, the electronic circuit system 130 is configured tooutput a first electronic output OP1 when the first medicament deliverydevice 150 is removed from the internal region 112 of the container 110,as indicated by the arrow A. As discussed in more detail herein, thefirst electronic output OP1 can be associated with an identification ofthe first medicament delivery device 150, an identification of aphysical condition and/or an instruction for using the first medicamentdelivery device 150. Moreover, the first electronic output OP1 caninclude a visual output, an audible output and/or a haptic output. Forexample, in some embodiments, the first electronic output OP1 can beassociated with an audible message instructing a user in the use of thefirst medicament delivery device 150. Such an audible message can state,for example, “You have removed an auto-injector containing Epinephrine.To actuate the auto-injector, first remove the red safety tab located atthe end of the auto-injector.” In other embodiments, for example, thefirst electronic output OP1 can be associated with a visual text messageinstructing to perform a series of tests on and/or observe the symptomsexhibited by a patient to determine whether the patient is sufferingfrom a certain physical condition (e.g., anaphylactic shock).

Similarly, as shown in FIG. 3, the electronic circuit system 130 isconfigured to output a second electronic output OP2 when the secondmedicament delivery device 152 is removed from the internal region 112of the container 110, as indicated by the arrow B. The second electronicoutput OP2, which is different than the first electronic output OP1, caninclude a visual output, an audible output and/or a haptic output.Moreover, as with the first electronic output OP1, the second electronicoutput OP2 can be associated with at least one of an identification ofthe second medicament delivery device 152, an identification of aphysical condition and/or an instruction for using the second medicamentdelivery device 152. In this manner, the electronic circuit system 130can provide the user with information about the particular medicamentdelivery device that has been removed from the container 110.

Although the second electronic output OP2 is described as beingdifferent than the first electronic output OP1, in some embodiments, thesecond electronic output OP2 can be the same as the first electronicoutput OP1. In some embodiments, for example, the second electronicoutput OP2 can include the same information as previously output via thefirst electronic output OP1 along with additional information. In thismanner, the second electronic output OP2 can confirm the instructionsand/or information provided by the first electronic output OP1.

The container 110 can be any container suitable for containing aplurality of medicament delivery devices. For example, in someembodiments, the container 110 can be a box-like structure that includesa lid or cover that can be repeatedly opened and closed to selectivelyexpose the internal region 112 of the container 110 to an area outsidethe container 110. In other embodiments, the container 110 can include afrangible portion that can be irreversibly moved to expose the internalregion 112 of the container 110 to allow access to the first medicamentdelivery device 150 and/or the second medicament delivery device 152.

The container 110 can be either portable or permanently installed at aparticular location. For example, in some embodiments, the container 110can be configured to be moved by the user. For example, in suchembodiments, a user may carry the container 110 to events, such aspicnics, field trips, children's camps or the like, where the likelihoodof use increases. In other embodiments, the container 110 can beremovably coupled to a mounting area within a building, such as arestaurant, airport and/or shopping mall. In this manner, when a userrecognizes an emergency situation, the user can locate the container 110and move it to the area in which the emergency situation is occurring.In yet other embodiments, the container 110 can be permanently coupledto a wall of a building.

The container 110 can be constructed from any suitable material, suchas, for example, plastic, metal alloys, insulative foam, fabric or anycombination thereof. In some embodiments, for example, the container 110can include a hard, plastic outer casing and an insulative,shock-absorbing inner liner. In some embodiments, the container 110 canbe constructed from a waterproof material and/or can be configured tofloat. In some embodiments, the container 110 can be constructed from amaterial configured to prevent light from reaching the interior region112 of the container. In this manner, the container can prevent themedicaments contained therein from being exposed to light that canimpact the chemical structure and/or stability of the medicament.

Although the container 110 is shown and described above as containing afirst medicament delivery device 150 and a second medicament deliverydevice 152 having similar sizes and/or shapes, in some embodiments, acontainer can be configured to include medicament delivery devices ofdifferent sizes and/or shapes. For example, in some embodiments, acontainer can be configured to include a medical injector having a long,narrow shape and an inhaler having a wider shape.

FIGS. 4-6 are schematic illustrations of a medical device 200 accordingto one such embodiment of the invention in a first configuration, asecond configuration and a third configuration, respectively. Themedical device 200 includes a container 210 including an electroniccircuit system 230 and defining an internal region 212. The internalregion 212 includes a first retainer 214 and a second retainer 216. Thefirst retainer 214 retains a first medicament delivery device 250 withinthe internal region 212 of the container. Similarly, the second retainer216 retains a second medicament delivery device 252 within the internalregion 212 of the container.

The electronic circuit system 230 includes a first switch 236 associatedwith the first retainer 214 and a second switch 237 associated with thesecond retainer 216. The first switch 236 is configured move between afirst state (e.g., closed) and a second state (e.g., opened) when thefirst medicament delivery device 250 is removed from the first retainer214. Similarly, the second switch 237 is configured move between a firststate and a second state when the second medicament delivery device 252is removed from the second retainer 216. In this manner, the electroniccircuit system 230 can output electronic outputs based on the state ofthe first switch 236 and/or the second switch 237.

More particularly, as shown in FIG. 5, the electronic circuit system 230is configured to output a first electronic output OP3, of the typedescribed above, when the first medicament delivery device 250 isremoved from the first retainer 214, as indicated by the arrow C.Similarly, as shown in FIG. 6, the electronic circuit system 230 isconfigured to output a second electronic output OP4, of the typedescribed above, when the second medicament delivery device 252 isremoved from the second retainer 216, as indicated by the arrow D. Saidanother way, the electronic circuit system 230 is configured to outputthe first electronic output OP3 in response to the first switch 236moving between its first state and its second state. Similarly, theelectronic circuit system 230 is configured to output the secondelectronic output OP4 in response to the second switch 237 movingbetween its first state and its second state.

The first retainer 214 can be any structure that cooperates with thefirst medicament delivery device 250 to retain the first medicamentdelivery device 250 within the internal region 212 of the container 210.Similarly, the second retainer 216 can be any structure that cooperateswith the second medicament delivery device 252 to retain the secondmedicament delivery device 252 within the internal region 212 of thecontainer 210. In some embodiments, for example, the first retainer 214can be a recessed portion (not shown in FIGS. 4-6) of the internalregion 212 having a shape to receive at least a portion of the firstmedicament delivery device 250. Such a recess can include, for example,an edge, a contour or a ridge that forms an interference fit with aportion of the first medicament delivery device 250 when the firstmedicament delivery device 250 is received within the first retainer214. In other embodiments, for example, the first retainer 214 and/orthe second retainer 216 can be a clip configured to engage a portion ofthe first medicament delivery device 250 and/or the second medicamentdelivery device 252, respectively, to retain the first medicamentdelivery device 250 and/or the second medicament delivery device 252 inthe internal region 212. In yet other embodiments, the first retainer214 and/or the second retainer 216 can be an elastic member, such as anelastic band configured to engage a portion of the first medicamentdelivery device 250 and/or the second medicament delivery device 252. Inyet other embodiments, the first retainer 214 and/or the second retainer216 can include a frangible member, such as a removable plastic coveringconfigured to retain the first medicament delivery device 250 and/or thesecond medicament delivery device 252 in the internal region 212.

In some embodiments, the first retainer 214 can be uniquely associatedwith the first medicament delivery device 250 and/or the second retainer214 can be uniquely associated with the second medicament deliverydevice 252. In this manner, the first medicament delivery device 250 canonly be associated with the first switch 236 and the second medicamentdelivery device 252 can only be associated with the second switch 237.Said another way, such an arrangement prevents second medicamentdelivery 252 from inadvertently being retained by the first retainer214, which could result in the electronic circuit system 230 outputtingthe first electronic output OP3 when the second medicament deliverydevice 252 is removed from the container 210 or vice-versa. Moreover, byusing the first retainer 214 and the second retainer 216, the internalregion 212 can be adapted to contain a variety of different medicamentdelivery devices having different sizes, shapes and/or characteristics.For example, in those embodiments in which the first retainer 214 is arecessed portion of the internal region 212, the shape of the recess canbe uniquely associated with a shape of the first medicament deliverydevice 250, thereby preventing the second medicament delivery device 252from being received within the first retainer 214. Similarly, in someembodiments, the second retainer 216 can be a recessed portion of theinternal region 212, of the type described above, having a shape toreceive at least a portion of the second medicament delivery device 252.

Although the retainers are described above as cooperating with themedicament delivery devices to retain the medicament delivery deviceswithin the internal region 212 of the container 210, in someembodiments, the first retainer 214 and/or the second retainer 216 canperform additional functions. For example, in some embodiments, thefirst retainer 214 can electronically couple an electronic circuitsystem (not shown in FIGS. 4-6) disposed on the first medicamentdelivery device 250 to the electronic circuit system 230. The electroniccircuit system included in the first medicament delivery device 250 canbe of the type shown and described in U.S. patent application Ser. No.11/621,236, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Jan. 9, 2007, which is incorporated herein by referencein its entirety. Similarly, the second retainer 216 can electronicallycouple an electronic circuit system (not shown in FIGS. 4-6) disposed onthe second medicament delivery device 252 to the electronic circuitsystem 230. In this manner, the first retainer 214 and/or the secondretainer 216 can be used as a battery charging port, a data exchangeport or the like.

FIG. 7 is a schematic illustration of a medical device 300 according toan embodiment of the invention. Because the medical device 300 issimilar in many respects to the medical devices shown and describedabove, the medical device 300 is shown in only one configuration. Themedical device 300 includes a container 310 including an electroniccircuit system 330 and defining an internal region 312. The internalregion 312 includes a first medicament delivery device 350 and a secondmedicament delivery device 352 of the types described above.

The electronic circuit system 330 is configured to output a firstelectronic output (not shown in FIG. 7), of the type described above,when the first medicament delivery device 350 is removed from theinternal region 312 of the container 310. Similarly the electroniccircuit system 330 is configured to output a second electronic output(not shown in FIG. 7), of the type described above, when the secondmedicament delivery device 352 is removed from the internal region 312of the container 310.

Moreover, as shown in FIG. 7, the first medicament delivery device 350includes a label 354, such as, for example, a radio frequencyidentification (“RFID”) tag, configured to output a signal S that can bereceived by the electronic circuit system 330. In some embodiments, thesignal S can indicate the position of the first medicament deliverydevice 350 (e.g., whether the first medicament delivery device 350 isoutside the internal region 312). In other embodiments, the signal S caninclude information characterizing the first medicament delivery device350. For example, in some embodiments, the signal S can be associatedwith the contents of the first medicament delivery device 350 (e.g., theamount and type of medicament contained therein), an expiration date ofthe first medicament delivery device 350, a dosage of the firstmedicament delivery device 350 and/or a use instruction associated withthe first medicament delivery device 350. In this manner, the electroniccircuit system 330 can receive the signal S and produce the firstelectronic output (not shown in FIG. 7) to include information containedwithin the signal S. Said another way, this arrangement allows theelectronic circuit system 330 to produce an electronic output that isunique to the medicament delivery devices contained within the container310.

In some embodiments, for example, the first electronic output can beassociated with an audible message including information contained fromthe signal S, such as for example, the expiration date of the medicamentcontained within the first medicament delivery device 350. Such anaudible message can state, for example, “You have removed anauto-injector containing DOSE mg of Epinephrine. The expiration date ofthis device is EXPIRATION DATE. If the current date is later thanEXPIRATION DATE please select another auto-injector from within thecontainer.” In other embodiments, for example, the first electronicoutput can be a message providing the user with use instructions orother information contained within the signal S that is uniquelyassociated with the first medicament delivery device 350. For example,such a message can prompt a user to call a phone number unique to themanufacturer of the first medicament delivery device 350 for assistancebefore, during or after the use of the first medicament delivery device350. In yet other embodiments, as described in more detail herein, theelectronic circuit system 330 can automatically call such a phone numberwhen the first medicament delivery device 350 is removed from theinternal region 312 of the container 310.

The label 354 can be any device suitable for outputting the signal Sthat includes information associated with the first medicament deliverydevice 350 and that can be received by the electronic circuit system330. For example, in some embodiments, the label 354 can include apassive RFID tag. In other embodiments, the label can include an activeRFID tag.

In some embodiments, label 354 can include its own electronic circuitsystem, similar to the electronic circuit systems described in U.S.patent application Ser. No. 11/621,236, entitled “Devices, Systems andMethods for Medicament Delivery,” filed Jan. 9, 2007, which isincorporated herein by reference in its entirety. In such embodiments,the label 354 can produce multiple signals associated with the firstmedicament delivery device 350 based on the ongoing status of themedicament delivery device 350 as determined by the electronic circuitsystem included within the label 354. For example, in some embodiments,the first medicament delivery device 350 can include its own electroniccircuit system having various switches, sensors or the like, such thatwhen the user completes certain operations (e.g., removing the needleguard, removing the safety tab, etc.), a signal S can be transmitted tothe electronic circuit system 330 of the container 310. The electroniccircuit system 330 of the container 310 can then output one or moreelectronic outputs of the type described above to provide information tothe user that is unique to the status of the first medicament deliverydevice 350.

Although the label 354 is shown and described as outputting a signal Sthat can be received by the electronic circuit system 330, in otherembodiments, the label 354 can be a passive device that does not outputan electronic signal, but rather, contains information associated withthe medicament delivery device 350 in a machine-readable format. Forexample, in such embodiments, the label 354 can include a bar codeportion containing information associated with the medicament deliverydevice 350. In other embodiments, the label 354 can include a magneticstrip containing information associated with the medicament deliverydevice 350.

The electronic circuit systems shown and described above can includemany components operatively coupled to perform the functions describedherein For example, FIG. 8 is a schematic illustration of an electroniccircuit system 430 according to an embodiment of the invention. Theelectronic circuit system 430 includes a processor 432 operativelycoupled to a memory device 434. The memory device 434 can be configuredto store processor-readable code 435 instructing the processor 432 toperform the functions described herein. In some embodiments, theprocessor-readable code 435 can be modified and/or updated ascircumstances dictate. The electronic circuit system 430 includes aninput/output device 446 configured to receive electronic inputs from afirst switch 436 and/or a second switch 437. In some embodiments, theinput/output device 446 can receive inputs from an RFID tag (asdescribed above), the user's voice (e.g., through a microphone), akeyboard, a touch screen, a proximity sensor and/or any other suitabledevice. The input/output device 446 is also configured to provideelectronic signals to various output devices, such as, for example, avisual output device 442, an audio output device 444, a haptic outputdevice (not shown in FIG. 8) a wireless receiver (e.g., an RFID tag, acellular phone system or the like) and/or a wired receiver (e.g., awired network).

The visual output device 442 can be any suitable device for producingvisual indicia, such as, light-emitting diodes (LEDs), liquid-crystaldisplay (LCD) screens, optical polymers, fiber optic components or thelike. Similarly, the audio output device 444 can be any suitable devicefor producing sound, such as a micro-speaker a piezo-electric transduceror the like. Such sound output can include, for example, an alarm, aseries of beeps, recorded speech or the like.

In some embodiments, the electronic circuit system 430 includes anetwork interface 440 configured to operatively couple the electroniccircuit system 430 to a remote device 441, either via a wired connectionor via a wireless connection. The remote device 441 can be, for example,a remote communications network, a computer, a cell phone, a personaldigital assistant (PDA) or the like. Such an arrangement can be used,for example, to download replacement processor-readable code 435 from acentral network to the memory device 434. In some embodiments, theelectronic circuit system 430 can download information associated with amedicament delivery device, such as an expiration date, a recall notice,updated use instructions or the like.

The network interface 440 can also be configured to transmit informationfrom the electronic circuit system 430 to a central network, such as,for example, an emergency response network. In some embodiments, forexample, the electronic circuit system 430 can notify an emergencyresponder when a medicament delivery device is removed and/or actuated.In other embodiments, the electronic circuit system 430 can transmitinformation to a third party, such as a physician, an emergency contactand/or the manufacturer of a medicament device, when the medicamentdelivery device is removed and/or actuated. Such information caninclude, for example, the location of use, the date and/or time of useor the like.

As shown in FIG. 8, power is supplied to the electronic circuit system430 by a power source 448. The power source 448 can be any suitablepower source, such as, for example, a DC power source and/or an AC powersource. In some embodiments, for example, power can be provided to theelectronic circuit system 430 by an AC circuit within the building inwhich the medical device is located. In other embodiments, power can beprovided to the electronic circuit system 430 by one or more batteries.In yet other embodiments, power can be provided to the electroniccircuit system 430 by both an AC circuit (e.g. as the primary source ofpower) and by batteries (e.g. as the secondary source of power). In yetother embodiments, the electronic circuit system 430 can be powered byany suitable energy storage device, such as, for example, a capacitor,solar cell or the like.

The processor 432 can be a commercially-available processing devicededicated to performing one or more specific tasks. For example, in someembodiments, the microprocessor 432 can be a commercially-availablemicroprocessor, such as the Sonix SNC 12060 voice synthesizer.Alternatively, the processor 432 can be an application-specificintegrated circuit (ASIC) or a combination of ASICs, which are designedto perform one or more specific functions. In yet other embodiments, theprocessor 132 can be an analog or digital circuit, or a combination ofmultiple circuits.

The memory device 434 can include one or more types of memory. Forexample, in some embodiments, the memory device 434 can include a readonly memory (ROM) component and a random access memory (RAM) component.The memory device 432 can also include other types of memory suitablefor storing data in a form retrievable by the processor 432, forexample, electronically-programmable read only memory (EPROM), erasableelectronically-programmable read only memory (EEPROM) and/or flashmemory.

Although the medical devices shown and described above include oneelectronic circuit system, in some embodiments, a medical device caninclude multiple electronic circuit systems configured to perform thefunctions described herein.

Although the containers shown and described above include multiplemedicament delivery devices, in some embodiments, a container caninclude only one medicament delivery device. For example, FIGS. 9-11show a medical device 500 including a container 510 that contains amedicament delivery device 550, such as, for example a pen injector oran auto-injector. As described above, the container 510 defines aninternal region 512 in which the medicament delivery device 550 iscontained. The container includes an electronic circuit system 530configured to produce one or more electronic outputs of the typedescribed above. More particularly, the electronic circuit system 530includes a speaker 544 and an LCD screen 542.

The container 510 also includes a movable portion 518, such as, forexample, a hinged lid, that has a first position (see FIG. 9) and asecond position (see FIGS. 10-11). When the movable portion 518 is inthe first position, the movable portion 518 covers the internal region512 of the container 510. Conversely, when the movable portion 518 is inthe second position, at least a portion of the internal region 512 ofthe container 510 is exposed. Said another way, when the movable portion518 is in the second position, the medicament delivery device 550 can beremoved from the internal region 512 of the container 510.

The electronic circuit system 530 is operatively coupled to a firstswitch 536 and a second switch 537. The first switch 536 is configuredto move between a first state (e.g., closed) and a second state (e.g.,opened) when the movable portion 518 moves between its first positionand its second position, as indicated by arrow E in FIG. 10. Theelectronic circuit system 530 is configured to output a first output OP5via the speaker 544 when the first switch 536 is moved from its firststate to its second state. The first output OP5 can be a recorded speechoutput associated with an identification of the medicament deliverydevice 550, an identification of patient symptoms (e.g., instructionsfor assessing the physical condition of the patient) and/or aninstruction for using the medicament delivery device 550. For example,in some embodiments the first output OP5 can state “You have activatedthe allergic reaction response kit. This kit includes an auto-injectorcontaining DOSE mg of Epinephrine. Before using this auto-injector,please ensure that the patient is exhibiting the following symptoms . .. ” Although described as an audible output, in other embodiments, thefirst output OP5 can be any type of electronic output as describedabove.

The second switch 537 is configured to move between a first state (e.g.,closed) and a second state (e.g., opened) when the medicament deliverydevice 550 is removed from the internal region 512 of the container 510,as indicated by the arrow F in FIG. 11. The electronic circuit system530 is configured to output a second output OP6 via the speaker 544and/or the LCD screen 542 when the second switch 537 is moved from itsfirst state to its second state. The second output OP6 can be, forexample, a recorded speech output and/or a video output associated withan identification of the medicament delivery device 550, anidentification of patient symptoms (e.g., instructions for assessing thephysical condition of the patient) and/or an instruction for using themedicament delivery device 550. For example, in some embodiments thesecond output OP6 can be an audio-visual output via both the speaker 544and the LCD screen 542 providing step-by-step instructions for using themedicament delivery device 550.

Although the movable member 518 is shown and described as being a hingedlid, in some embodiments, the movable member can be coupled to thecontainer in any suitable fashion. For example, in some embodiments, themovable member 518 can be a removable cover that is slidingly coupled tothe container. In other embodiments, the movable member 518 can be aremovable cover that is threadedly coupled to the container (i.e., aremovable cap). In yet other embodiments, the movable member 518 can bea removable cover that is coupled to the container via an interferencefit. In yet other embodiments, the movable member 518 can be a frangiblecover that is irreversibly removed from the container during use of themedical device. For example, in some embodiments the movable member 518can be a frangible cover that provides a tamperproof seal, a sanitaryseal, or the like.

Although the containers are shown and described above as being rigid,box-like containers, in other embodiments, a container can have anysuitable shape and/or flexibility. For example, in some embodiments, acontainer can be a flexible, pouch-like container. Such a container canbe more easily carried in certain circumstances, such as, for example atoutdoor events (e.g., children's camps, concerts, picnics or the like).In other embodiments, a container can be a tube configured to containall or a portion of a medicament delivery device. For example, FIGS.12-14 show a medical device 600 including a tube-shaped container 610and a retainer 618. The container 610 defines an internal region 612(see FIG. 15) in which at least a portion of a medicament deliverydevice 650 can be contained.

The retainer 618, which can be, for example, a mating tube-shaped lid,is movably coupled to the container 610 to retain the medicamentdelivery device 650 within the internal region 612. Said another way,the retainer 618 has a first position (FIG. 12) and a second position(FIG. 13). When the retainer 618 is in the first position, the retainer618 prevents the medicament delivery device 650 from being removed fromthe internal region 612 of the container 610. When the retainer 618 isin the second position, the medicament delivery device 650 can beremoved from the internal region 612 of the container 610.

The medical device 600 includes an electronic circuit system 630 coupledto the container 610. The electronic circuit system 630 includes aspeaker 644 and a light emitting diode (LED) 642 for providing anelectronic output associated with the use of the medicament deliverydevice 650, as described herein. In some embodiments, the electroniccircuit system can be, for example, a flexible circuit included in alabel coupled to an outer surface of the container 610, similar to theelectronic circuit systems described in U.S. patent application Ser. No.11/621,236, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Jan. 9, 2007, which is incorporated herein by referencein its entirety.

The electronic circuit system 630 is configured to output a firstelectronic output via the LED 642 and/or the speaker 644 when theretainer 618 is moved relative to the container 610, as indicated byarrows G and/or G′ in FIG. 13. As described above, the first electronicoutput can be associated with an identification of the medicamentdelivery device 650, an identification of a physical condition and/or aninstruction for using the medicament delivery device 650. For example,in some embodiments, the first electronic output can be associated withan audible message instructing a user in the use of the medicamentdelivery device 650. Such an audible message can state, for example,“You have activated an interactive auto-injector containing DOSE mg ofEpinephrine. Please remove the top of the container by twisting andpulling as indicated by the flashing arrow. After removing the top ofthe container, please remove the auto-injector from the container byfirmly pulling on the exposed end of the auto-injector.”

The electronic circuit system 630 can be prompted to output the firstelectronic output by a switch 636 configured to change states when theretainer 618 is moved relative to the container 610. The switch 636 canbe any suitable electronic switch having at least two states. Forexample, in some embodiments, the switch 636 can be a single-use“tear-through” switch, as described in U.S. patent application Ser. No.11/621,236, entitled “Devices, Systems and Methods for MedicamentDelivery,” filed Jan. 9, 2007, which is incorporated herein by referencein its entirety. For example, the switch 636 can be irreversibly movedfrom a first state to a second state when the retainer 618 is movedrelative to the container 610. In other embodiments, a switch can be amulti-use switch, such as a microswitch.

Similarly, the electronic circuit system 630 is configured to output asecond electronic output via the LED 642 and/or the speaker 644 when themedicament delivery device 650 is removed from the internal region 612defined by the container 610, as shown by arrow H in FIG. 14. The secondelectronic output can be associated with an identification of themedicament delivery device 650, an identification of a physicalcondition and/or an instruction for using the medicament delivery device650. For example, in some embodiments, the second electronic output canbe an audible message stating, “To activate the auto-injector, firstremove the needle guard. The needle guard is at the bottom of theauto-injector and contains the number one inside of an arrow pointingdownward. Remove the needle guard by pulling in the direction of thearrow.”

As shown in FIG. 14, the medicament delivery device 650 includes a label654 containing information associated with the medicament deliverydevice 650 arranged in a machine-readable format. The electronic circuitsystem 630 is configured to receive (e.g., “read”) the informationcontained in the label 654 and include at least a portion of theinformation in the first electronic output and/or the second electronicoutput. In this manner, the electronic circuit system 630 can beconfigured to produce an electronic output that is unique to themedicament delivery device 650 contained within the container 610. Thisarrangement allows the container 610 to be reused with any number ofdifferent medicament delivery devices 650. Moreover, this arrangementallows the container 610 to track the usage of a chronic-care medicamentdelivery devices. For example, in some embodiments, the electroniccircuit system 630 can track each use of the medicament delivery device650 and log such information on the label 654.

The label 654 can be any device suitable for containing informationassociated with the medicament delivery device 650 in a machine-readableformat. For example, in some embodiments, the label 654 can include abar code portion containing information associated with the medicamentdelivery device 650. In other embodiments, the label 654 can include amagnetic strip containing information associated with the medicamentdelivery device 650. In yet other embodiments, the label 654 can includea passive RFID tag containing information associated with the medicamentdelivery device 650. In yet other embodiments, the label 654 can includean active RFID tag containing information associated with the medicamentdelivery device 650.

Although the retainer 618 is shown as covering the internal region 612defined by the container 610, in some embodiments, the retainer 618 canallow access to the internal region 612 while still retaining themedicament delivery device 650 within the internal region 612. Forexample, in some embodiments, the retainer 618 can be a clip, a strap orthe like.

Although the medicament delivery device 650 is shown in FIGS. 12-13 asbeing disposed entirely within the container 610 and the retainer 618,in some embodiments, only a portion of the medicament delivery device650 is disposed within the container 610 and/or the retainer 618. Forexample, in some embodiments, a container can be a sleeve configured tobe disposed about a portion of a medicament delivery device, such as achronic care pen injector. The retainer can function to retain the peninjector within the sleeve and/or to prevent the pen injector from beingactuated (e.g., the retainer can act as a locking member). In use, theuser can activate the electronic circuit system by depressing a startbutton disposed on the container. Alternatively, in some embodiments,the electronic circuit system can be activated by removing the retainerfrom the pen injector and/or the container. In yet other embodiments,the electronic circuit system can be activated by moving the peninjector relative to the container (i.e., twisting the pen injectorwithin the container). Upon activation, the electronic circuit systemthen “reads” a label and outputs a first electronic output and/or asecond electronic output, as described above.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, although electronic circuit systems are shown and describedabove as outputting one or more outputs directed towards a single,immediate user, in some embodiments, an electronic circuit system canoutput multiple outputs directed towards multiple different classes ofusers. For example, in some embodiments, an electronic circuit systemcan output a first electronic output to the immediate user and secondelectronic output to a remotely located emergency response team. In suchembodiments, the second electronic output can be, for example, a phonecall, a page, an e-mail or the like. For example, in some embodiments,the second electronic output can be an e-mail to the parents and/orcaregivers of a child. Moreover, such a second electronic output can betransmitted either wirelessly or through a wired network.

Although the electronic circuit systems are shown and described above asoutputting one or more outputs in response to one or more switches, inother embodiments an electronic circuit system can output an electronicoutput in response to any number of different inputs. For example, insome embodiments, an electronic circuit system can output an electronicoutput based on input from the user provided via a keyboard, a touchscreen, a microphone or any other suitable input device. In this manner,the electronic outputs can be produced in response to direct feedbackfrom the user.

In other embodiments, an electronic circuit system can output anelectronic output based on a sensor included in the container and/or themedicament delivery device. Such a sensor can include, for example, aproximity sensor (e.g., to determine the position of the medicamentdelivery device), a temperature sensor, a pressure sensor, an opticalsensor or the like. For example, in some embodiments, the container caninclude a temperature sensor configured to sense the temperature of themedicament contained within the medicament delivery device. In thismanner, the electronic circuit system can output an instruction and/or astatus message when the medicament is too cold for effective delivery.For example, in some embodiments, when the medicament is too cold foreffective delivery (this may occur, for example, if the container isbeing used in an outdoor setting), the electronic circuit system canoutput a message, such as, for example, “Medicament is too cold—pleasebriskly rub the auto-injector between your hands before using.”

Although the electronic circuit systems are shown and described above asoutputting a single electronic output in response to an input (e.g., theremoval of a medicament delivery device, the change in position of ahinged lid, etc.), in some embodiments, an electronic circuit system canoutput a sequence of electronic outputs in response to such an input. Insome embodiments, for example, when a medicament delivery device isremoved from a container, an electronic circuit system can output apredetermined sequence of use instructions over a predetermined timeperiod. For example, upon removing the medicament delivery device, thefirst instruction can be an audible output indicating the type ofmedicament delivery device removed. After a predetermined time period,the electronic circuit system can then output a second instruction,which can be a visual output instructing the user in how to diagnose thepatient and/or prepare the patient for the medicament. In a similarmanner, the electronic circuit system can provide additional outputs toinstruct the user in the use of the medicament delivery device.Moreover, in some embodiments, the electronic circuit system can outputan electronic output instructing the user in post-use procedures, suchas for example, the disposal of the medicament delivery device,instructions for follow-up treatment or the like.

For example, although the electronic circuit systems are shown anddescribed above as being configured to output primarily audible andvisual outputs, in other embodiments, an electronic circuit system canbe configured to produce any suitable output. For example, in someembodiments, an electronic circuit system can produce a haptic output,such as a vibratory output produced by a piezo-electric actuator. Inother embodiments, an electronic circuit system can produce a thermaloutput, produced by a heating or cooling element.

Although the electronic circuit systems are shown and described above asoutputting recorded speech in English, in other embodiments, theelectronic circuit system can output recorded speech in any language. Inyet other embodiments, the electronic circuit system can output recordedspeech in multiple languages. In yet other embodiments, the user canselect the language in which the recorded speech is to be output.

Although the medicament delivery devices have been shown and describedabove as being primarily single-use medical injectors, in someembodiments a medicament delivery device can include any suitable devicefor delivering one or more doses of a medicament into a patient's body.For example, in some embodiments, a medicament delivery device can be apen injector containing multiple doses of a chronic-care medicament,such as, for example, insulin. In such embodiments, an electroniccircuit system can output instructions associated with not only aninitial use of the medicament delivery device, but also associated withrepeated uses, dosage monitoring or the like. In other embodiments, amedicament delivery device can include a transdermal medicament deliverydevice, an inhaler or a nasal medicament delivery device.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, in some embodiments amedical device can include a container including an electronic circuitsystem, two or more medicament delivery devices and a movable portion.In such embodiments, each of the medicament delivery devices can beassociated with a switch. Moreover, the movable portion can also beassociated with a switch. In this manner, the electronic circuit systemcan be configured to output a first electronic output when the movableportion is moved, a second electronic output when the first medicamentdelivery device is removed from the container and a third electronicoutput when the second medicament delivery device is removed from thecontainer.

1. An apparatus, comprising: a container defining an internal regionconfigured to contain at least a portion of a medicament deliverydevice; a retainer configured to be movably coupled to the container,the retainer configured to retain the portion of the medicament deliverydevice within the internal region; and an electronic circuit systemincluding a switch disposed on a printed circuit board, the electroniccircuit system configured to output a first electronic output when theswitch is moved from a first state to a second state, the electroniccircuit system configured to output a second electronic output when themedicament delivery device is removed from the internal region; aportion of the retainer configured to tear a portion of the printedcircuit board to irreversibly move the switch from the first state tothe second state when the retainer is moved relative to the container.2. The apparatus of claim 1, wherein: the first electronic outputincludes at least one of a visual output, an audible output, a hapticoutput, a wireless communications signal or a wired communicationssignal; and the second electronic output includes at least one of avisual output, an audible output, a haptic output, a wirelesscommunications signal or a wired communications signal.
 3. The apparatusof claim 1, wherein at least one of the first electronic output or thesecond electronic output includes recorded speech.
 4. The apparatus ofclaim 1, wherein the first electronic output is associated with any oneof an identification of the medicament delivery device, anidentification of a physical condition, or an instruction for using themedicament delivery device.
 5. The apparatus of claim 1, wherein thesecond electronic output is associated with at least one of anidentification of the medicament delivery device, an identification of aphysical condition or an instruction for using the medicament deliverydevice.
 6. The apparatus of claim 1, wherein the medicament deliverydevice is at least one of a pen injector, an auto-injector or aninhaler.
 7. The apparatus of claim 1, further comprising: a labelconfigured to be coupled to the medicament delivery device, the labelcontaining an information associated with the medicament deliverydevice, the information being arranged in a machine-readable format, theelectronic circuit system configured to receive the information, atleast one of the first electronic output or the second electronic outputincluding at least a portion of the information.
 8. The apparatus ofclaim 7, wherein the label includes at least one of a magnetic stripcontaining the information, a bar code portion containing theinformation or an radio frequency identification tag containing theinformation.
 9. The apparatus of claim 1, wherein at least one of thefirst electronic output or the second electronic output includes acommunications signal configured to notify an emergency response system.10. The apparatus of claim 1, wherein the second electronic output isunique to the medicament delivery device.